A Clinical Study to Evaluate Safety, Tolerability and Pharmacokinetics of Oral ZYGK1 in Healthy Volunteers

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The purpose of this study is to determine (1) whether ZYGK1 is safe and well tolerated, (2) the pharmacokinetics (what body does to ZYGK1) and (3) pharmacodynamics (what drugs does to the body) in the healthy and diabetic subject.

Condition or disease

Intervention/treatment

Phase

Diabetes

Drug: ZYGK1Drug: Placebo

Phase 1

Detailed Description:

This study will be a randomized, double blind, placebo controlled study and is divided into four plans:

Plan I: Single Ascending Dose (SAD) Study

Plan II: Multiple Ascending Dose (MAD)Study

Plan III: Gender Effect study

Plan IV: Food Effect study

First Plan I, Plan III and Plan IV will be conducted in healthy volunteers. After reviewing the results, decision shall be taken whether the multiple ascending doses shall be studied in healthy human volunteers or in subjects with type 2 diabetes.

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History or presence of other systemic disorders or diseases (e.g., respiratory, gastrointestinal, endocrine, immunological, dermatological, neurological, psychiatric disease or any other body system involvement)

Abnormal bleeding time (BT), clotting time (CT), prothrombin time (PT), and activated partial prothrombin time (APTT)

History or presence of any medication in the last 14 days

History or presence of significant alcoholism or drug abuse within the past 1 year

History or presence of significant smoking (more than 10 cigarettes per day) or consumption of tobacco products (more than 10 times per day)

Difficulty with donating blood

Systolic blood pressure more than 140 mmHg and less than 100 mmHg and diastolic blood pressure more than 90 mmHg and less than 60 mmHg

Pulse rate less than 60 minute and more than 100/minute

Any clinically significant laboratory findings during screening

History or presence of any clinically significant electrocardiogram (ECG) abnormalities during screening

Major illness and/or major surgery in last 3 months

Volunteers who have participated in any drug research study other than the present trial within past 3 months

Volunteers who have donated one unit (350 ml) of blood in the past 3 months